Document Detail

Tramadol drops in children: analgesic efficacy, lack of respiratory effects, and normal recovery times.
MedLine Citation:
PMID:  11692348     Owner:  NLM     Status:  MEDLINE    
Tramadol hydrochloride is a racemic mixture of two enantiomers. It has analgesic activity suitable for mild to moderate pain, part of its analgesic activity being modulated via mu receptors. Adult studies have raised the question of increased electroencephalographic activity. The study examined the analgesic efficacy, respiratory effects, and behavior plus recovery-influencing properties of tramadol in the pediatric patient. Day-case dental extraction children, aged 4-7 years having 6 or more extractions, were studied. Tramadol drops, 3 mg/kg, plus oral midazolam, 0.5 mg/kg, were administered 30 minutes prior to a sevoflurane in N2O and O2 anesthetic. Forty children received this premedication treatment (T) and 10 entered a placebo control group (P), where no tramadol was administered. Entry was random, double blind, and parallel. Analgesic efficacy was measured using the Oucher face pain scale (OFPS), with responders scoring three or less. Respiration was measured by rate and oxygen saturation. Behavior and ease of mask induction were assessed on a 4-point scale. Recovery was measured with the Aldrete scale. Parameters were measured from 30 minute preanesthetic to 120 minute postanesthetic. Analgesic efficacy was shown, with an OFPS score of 11.42 (SD 18.66) (T) and 29.80 (SD 25.14) (P) (P < .05). Responders on tramadol were 77.5% versus 0% on placebo (P < .05). No respiratory depression was seen; rates and oxygen saturations were the same preanesthetic and postanesthetic. Similarly, the two groups had no cardiovascular differences. Preanesthetic behavior patterns were the same (P > .05), with 85% of the tramadol group being drowsy but awake versus 90% in the placebo group. Similarly satisfactory induction behavior was seen in 95% of the tramadol group and 90% of the placebo group. Recovery times were 48.6 minutes (SD 32.3) (T) and 43.1 minutes (SD 32.5) (P) (P > .05). It is concluded that tramadol at 3 mg/kg has no clinical respiratory depressant effect and that behavior and recovery times are unaffected. Analgesic efficacy is demonstrated.
K A Payne; J A Roelofse
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Anesthesia progress     Volume:  46     ISSN:  0003-3006     ISO Abbreviation:  Anesth Prog     Publication Date:  1999  
Date Detail:
Created Date:  2001-11-05     Completed Date:  2001-12-04     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0043533     Medline TA:  Anesth Prog     Country:  United States    
Other Details:
Languages:  eng     Pagination:  91-6     Citation Subset:  D    
2 Military Hospital, Wynberg, South Africa.
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MeSH Terms
Ambulatory Surgical Procedures
Analgesics, Opioid / administration & dosage,  therapeutic use*
Anesthesia Recovery Period*
Anesthetics, Inhalation / administration & dosage
Child Behavior / drug effects
Child, Preschool
Confidence Intervals
Double-Blind Method
Follow-Up Studies
Hypnotics and Sedatives / administration & dosage,  therapeutic use
Midazolam / administration & dosage,  therapeutic use
Oxygen / blood
Pain Measurement / methods
Respiration / drug effects*
Sleep Stages / drug effects
Statistics as Topic
Tooth Extraction
Tramadol / administration & dosage,  therapeutic use*
Treatment Outcome
Reg. No./Substance:
0/Analgesics, Opioid; 0/Anesthetics, Inhalation; 0/Hypnotics and Sedatives; 0/Placebos; 27203-92-5/Tramadol; 59467-70-8/Midazolam; 7782-44-7/Oxygen

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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